What It Means for FDA Operations and the Diagnostics Industry
SVP Global Regulatory and Quality
When the federal government shut down on October 1, 2025, the U.S. Food and Drug Administration (FDA) scaled back operations, focusing on authorized and essential public health functions. While the FDA remains open, its work is now limited to activities necessary to ensure public health and safety and those funded by carryover user fees — funds collected in prior fiscal years that remain available for use.
FDA staff continue to work on ongoing safety monitoring and active submission reviews, but most new submissions and longer-term initiatives are on hold until Congress passes a funding bill.
The official contingency plan from the U.S. Department of Health and Human Services (HHS) outlines how the FDA will operate during this lapse in appropriations.
You can view it here:
https://www.hhs.gov/about/budget/fy-2026-hhs-contingency-staffing-plan/index.html
FDA Priorities During the Lapse
The FDA continues to function with a reduced workforce — about 86% of its staff — consisting of:
- Exempt employees, whose work is supported by carryover user-fee funding or other existing resources.
- Excepted employees, whose duties are considered essential to protecting life or property.
These teams sustain FDA’s mission-critical operations: overseeing product safety, managing recalls, monitoring imports, and responding to urgent public health risks.
FDA Activities That Continue
During the shutdown, FDA continues the functions directly tied to immediate health and safety and those sustained by carryover user-fee balances. Carryover balances vary by program, meaning review activity may continue longer in some divisions than others. These include:
- Monitoring and responding to urgent safety threats, including product recalls and disease outbreaks.
- Conducting import surveillance and other product safety monitoring activities.
- Continuing review of existing premarket applications for drugs, biologics, and medical devices that were submitted and paid for before October 1.
- Conducting for-cause inspections and limited surveillance inspections.
- Maintaining oversight of ongoing clinical trials where participant safety could be at risk.
For diagnostic developers, this means premarket submissions already under review — such as 510(k)s, PMAs, or De Novo Classification Requests — may continue moving forward if previously funded, though applicants may experience a slower pace due to any reductions in staffing.
FDA Activities on Hold — and Why It Matters
Most other FDA activities are paused until Congress passes a new funding bill. These include:
- Acceptance and processing of new premarket submissions that require user-fee payment (e.g., new 510(k)s, PMAs, or De Novo Classification Requests).
- Scheduling of new advisory committee meetings or long-term policy development.
- Routine, non-critical inspections of manufacturing facilities.
- Hiring, staff training, and other internal improvement programs.
The FDA’s contingency plan also notes that regulatory science research and program development activities will pause. In practical terms, this means:
- Internal research that supports future policy or technical guidance (for example, performance standard development or model validation work) is temporarily halted.
- Upgrades to information technology systems, laboratories, and other infrastructure are postponed.
- Staff development, onboarding, and training are suspended.
While these slowdowns may not affect premarket reviews immediately, they can delay future guidance documents, modernization projects, and cross-agency initiatives — creating ripple effects that last beyond the shutdown itself.
What This Means for Diagnostic Developers
For diagnostic developers, the degree of impact will depend on both the type of submission and the timing of review activity relative to the funding lapse.
Ongoing Premarket Submission Reviews
If your diagnostic premarket application was already under review before October 1 and supported by an existing user-fee payment, FDA reviewers may continue their reviews.
However, applicants should plan for slower communication, longer response times, and possible scheduling changes if FDA resources are limited.
Q-Submissions (Pre-Submissions) and Investigational Device Exemption (IDE) Submissions
Q-Submissions (e.g., pre-submissions) and IDE submissions do not require user fees and therefore may still be accepted and reviewed, though timing may vary depending on available staff and competing priorities. As with premarket review submissions, the FDA’s ability to review these may be constrained during a funding lapse, and sponsors are advised to plan accordingly.
Maintaining Progress During the Shutdown
Even within these constraints, diagnostic sponsors can use this time effectively to maintain readiness and reduce delays when operations resume:
- Address outstanding FDA questions on submissions under review to maintain momentum.
- Refine planned documentation to ensure data packages, validation reports, and labeling are complete.
- Verify internal quality systems and maintain inspection readiness.
- Communicate realistic expectations to internal teams, partners, and other stakeholders regarding potential delays.
When Operations Resume
Once Congress enacts new appropriations, FDA will begin restoring full operations.
Historically, the FDA takes several weeks to re-engage fully, as review divisions re-prioritize pending work and reestablish schedules.
Sponsors can expect:
- Review clocks to restart.
- Rescheduling of postponed meetings or consultations.
- Gradual resumption of policy, guidance, and modernization initiatives.
Being prepared to re-engage quickly helps sponsors regain momentum once the FDA is fully operational.
How Beaufort Can Help
At Beaufort, we understand the pressures a funding lapse places on diagnostics developers — especially when review timelines, study initiation, and market planning depend on FDA availability.
Our team continues to work alongside clients during this period to:
- Assess regulatory impacts and adjust project timelines.
- Prepare and quality-check submissions so they are complete and ready for prompt filing once FDA operations resume.
- Strengthen documentation, validation, and QMS records to ensure post-shutdown readiness.
- Support ongoing clinical and regulatory activities that remain active during the lapse, including IDE oversight and study monitoring.
Our goal is to help sponsors maintain progress, minimize disruption, and be positioned to move forward the moment the FDA reopens.
Conclusion
The FY 2026 government shutdown has not closed the FDA, but it has limited the Agency’s ability to operate as usual.
Critical safety and review activities continue, but most new submissions, guidance development, and long-term policy work are paused until appropriations return.
For diagnostic developers, this period calls for focus and preparation. By maintaining documentation, communication, and compliance readiness now, sponsors can move quickly when the regulatory environment stabilizes.